TBI
Conditions
Keywords
PTSD, patient education handout
Brief summary
This research study is designed to learn about Veterans' understanding of mild TBI (traumatic brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the study-related clinics for TBI screening will be invited to participate. An educational handout on TBI will be given to half of the participants along with their TBI screening. The other half of the participants will have the usual TBI screening without the educational handout. Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire. The questionnaire will ask: * About the individual: such as gender and branch of service * About what happened during the TBI screening: such as whether the Veteran had a chance to ask the provider any questions * About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are long lasting Veterans who receive the educational handout will be asked specific questions about the handout and its information.
Detailed description
OBJECTIVE/HYPOTHESIS: The investigators propose to develop an educational handout on mild traumatic brain injury (mTBI) and to evaluate whether this brief, educational intervention improves knowledge and understanding of TBI and the screening results. The long-term goal is to promote expectations for a positive recovery in Veterans with mTBI. The specific aim is to evaluate the effect of the intervention on Veterans' knowledge and illness perceptions regarding TBI. Hypotheses are as follows: 1. Veterans who receive the educational intervention will have improved knowledge and understanding of TBI and the meaning of a positive TBI screen compared to Veterans who undergo screening as usual. 2. Veterans who screen positive for TBI and receive the educational intervention will have less negative illness perceptions regarding TBI compared to Veterans who screen positive in the control group. Secondary analyses are to identify clinic-level barriers and facilitators to incorporation of the educational handout into the clinical encounter. RESEARCH PLAN: The investigators will compare 2 groups of Veterans (N = 1500), half of whom are screened as usual and half of whom receive the educational intervention. Participants will be Veterans from 4 VA post-deployment clinics in Bay Pines, FL; Hampton, VA; Providence, RI; and Tampa, FL. The recruitment portion of the study will last 24 weeks at each site. The first 12 weeks of the study, all OEF/OIF Veterans that are screened for TBI will be enrolled into the screening as usual control group. The following 12 weeks all OEF/OIF Veterans screened for TBI will be enrolled into the intervention group. The investigators anticipate enrolling 750 Veterans in each group. METHODOLOGY: All OEF/OIF Veterans screened for TBI in the 4 identified post-deployment clinics during the study period will be eligible for inclusion in the study. The primary outcome is knowledge gained about mTBI and illness perception. All participants will be given an instrument with questions on demographics and TBI knowledge and perceptions. Participants who receive the educational handout will be asked for additional feedback. The investigators will examine the effect of the intervention on the number of correct responses to the knowledge items as well as the rates of correct answers to each individual knowledge item. Further, the investigators will examine the effect of the intervention on each of the illness perception scores.
Interventions
The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.
Sponsors
Study design
Eligibility
Inclusion criteria
* All OEF/OIF Veterans screened for TBI at the designated clinic at 1 of the 4 study sites (during the 6 months of recruitment) will be eligible.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mTBI Questionnaire | One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment. | The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions. |
| Illness Perception - Current Symptoms | One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment. | Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe. |
| Illness Perception - Duration of Symptoms | One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment. | Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Questionnaire | One month- Providers complete a questionnaire within 1 month after data collection ends for the site. | A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screened as Usual Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention. | 607 |
| TBI Handout Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover. | 629 |
| Total | 1,236 |
Baseline characteristics
| Characteristic | Screened as Usual | TBI Handout | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 287 participants | 306 participants | 593 participants |
| Age, Customized <20 years | 0 participants | 1 participants | 1 participants |
| Age, Customized 30-39 years | 152 participants | 158 participants | 310 participants |
| Age, Customized 40-49 years | 123 participants | 119 participants | 242 participants |
| Age, Customized 50-59 years | 39 participants | 38 participants | 77 participants |
| Age, Customized 60+ years | 5 participants | 1 participants | 6 participants |
| Employment Full-time | 178 participants | 197 participants | 375 participants |
| Employment Part-time | 37 participants | 27 participants | 64 participants |
| Employment Retired | 69 participants | 58 participants | 127 participants |
| Employment Student | 150 participants | 149 participants | 299 participants |
| Employment Unemployed | 170 participants | 191 participants | 361 participants |
| Marital status Divorced | 117 participants | 114 participants | 231 participants |
| Marital status Married | 269 participants | 300 participants | 569 participants |
| Marital status Never married | 171 participants | 161 participants | 332 participants |
| Marital status Separated | 42 participants | 44 participants | 86 participants |
| Marital status Widowed | 2 participants | 3 participants | 5 participants |
| Reported PTSD diagnosis No | 440 participants | 469 participants | 909 participants |
| Reported PTSD diagnosis Yes | 152 participants | 146 participants | 298 participants |
| Service Branch Air Force | 524 participants | 543 participants | 1067 participants |
| Service Branch Army | 346 participants | 335 participants | 681 participants |
| Service Branch Coast Guard | 599 participants | 617 participants | 1216 participants |
| Service Branch Marine Corps | 508 participants | 533 participants | 1041 participants |
| Service Branch National Guard | 529 participants | 571 participants | 1100 participants |
| Service Branch Navy | 463 participants | 477 participants | 940 participants |
| Service Branch Reserves | 570 participants | 581 participants | 1151 participants |
| Service connection No | 305 participants | 277 participants | 582 participants |
| Service connection Yes | 278 participants | 311 participants | 589 participants |
| Sex/Gender, Customized Female | 91 participants | 99 participants | 190 participants |
| Sex/Gender, Customized Male | 494 participants | 483 participants | 977 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Illness Perception - Current Symptoms
Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.
Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Population: All veterans who accepted questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Illness Perception - Current Symptoms | 6.92 units on a scale | Standard Deviation 2.46 |
| Arm 2 | Illness Perception - Current Symptoms | 6.79 units on a scale | Standard Deviation 2.4 |
Illness Perception - Duration of Symptoms
Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.
Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Population: All veterans screened who accepted questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Illness Perception - Duration of Symptoms | 7.59 units on a scale | Standard Deviation 2.55 |
| Arm 2 | Illness Perception - Duration of Symptoms | 7.61 units on a scale | Standard Deviation 2.5 |
mTBI Questionnaire
The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.
Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Population: All veterans screened who accepted the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | mTBI Questionnaire | 5.38 correct answers out of 10 | Standard Deviation 2.94 |
| Arm 2 | mTBI Questionnaire | 7.52 correct answers out of 10 | Standard Deviation 2.65 |
Feasibility Questionnaire
A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.
Time frame: One month- Providers complete a questionnaire within 1 month after data collection ends for the site.
Population: PI and project staff no longer have access to this data to report results.